—#146250

Product

iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072079
Affected lot / code info: Software iGUIDE 2.1 and 2.2

Why it was recalled

If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.

Root cause (FDA determination)

Software design

Action the firm took

Elekta sent an Important Field Safety Notice that was distributed to all affected customers on May 12, 2016. The notice informs end users about the problem and the potential clinical impact. It also gives a recommendation how the risk can be mitigated. The notice also advises the customer that a patch will be released that will introduce a patch that avoids an inaccurate position and thus eliminates an unsafe situation. Corrective Action #2: Permanent Solution Software Upgrade A software patch will be released that will correct the behavior of the iGUIDE software. The target release date for this patch is January 2017. Service teams will have 6 months from the date of release to correct all affected devices in the field. For further questions, call (770) 300-9725.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan

Timeline

Recall initiated: 2016-05-12
Posted by FDA: 2016-05-23
Terminated: 2021-07-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #146250. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.